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Custom Telfa Pack

FDA UDI

Class II (US FDA UDI)

by American Surgical Company, LLC

Identity

Trade Name
Custom Telfa Pack FDA UDI
Generic Name
Neurosurgical sponge FDA UDI
Device Name
1/4" X 3" (qty 1), 3/8" X 3" (qty 1), 1/2" X 3" (qty 2), 3/4" X 3" (qty 1) FDA UDI
Model / Reference
82-01 FDA UDI
Description
1/4" X 3" (qty 1), 3/8" X 3" (qty 1), 1/2" X 3" (qty 2), 3/4" X 3" (qty 1) FDA UDI

Identifiers

Primary DI / UDI-DI
00749915002555 FDA UDI
510(k) Number
K904514 FDA UDI
FDA Product Code
HBA FDA UDI
GMDN Term
Neurosurgical sponge FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Neurosurgical sponge

Custom Telfa Pack by American Surgical Company, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurosurgical sponge.

Cleared under the same submission

K904514 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Surgical Company, LLC

Sources (1)

  • FDA UDI 24d12d95-7aa0-4512-b430-d48edd20cd61 34 fields · synced Jun 9, 2026